PRODUCT I N FOR MATION Fujirebio Diagnostics EIA Kit

Transcription

1 PRODUCT I N FOR MATION Fujirebio Diagnostics EIA Kit Only available outside the US

2 Working Together for Better Diagnostics Introduction Features and Benefits of EIA kits from Fujirebio Diagnostics Simple and robust protocols Ready to Use reagents Simple one and two-step sandwich assays Streptavidin coated microplates Proprietary, characterized, high affinity monoclonal antibodies Low sample volume Fujirebio Diagnostics is a world leader in in vitro diagnostics and the gold standard manufacturer of cancer biomarker assays worldwide. We have extensive expertise in the development, manufacturing, and commercialization of in vitro diagnostic products for a variety of disease states. Fujirebio Diagnostics range of antibodies against tumor antigens are the core of our assay kits, available in both manual assay formats (RIA and EIA) and as custom developed products for use through our partners systems worldwide. In 2006, CanAg Diagnostics merged with Fujirebio Diagnostics, Inc. to form the largest manufacturer of oncology biomarkers in the industry. Fujirebio Diagnostics have maintained the CanAg brand name for those EIA kits that CanAg customers around the world have come to associate with superior quality and reliability. Fujirebio Diagnostics is a fully owned subsidiary of Fujirebio Inc., Tokyo, Japan. Fujirebio Inc. was established in 1950 and its ultimate goal is to contribute to medical treatment and human welfare worldwide as a Global life science company. Fujirebio, Inc. has been a pioneer in the field of clinical diagnostics with a focus on cancer markers, infectious disease, hormone and thyroid testing. Quality Fujirebio Diagnostics is committed to providing quality products that meet the requirements of our customers. Our quality management system encompasses every aspect of product realization, from design through manufacturing and product shipment to allow us to achieve the high standards required by regulatory authorities and our customers. All in vitro diagnostic products are CE marked. The CE-mark indicates that the product complies with the requirements of the European In Vitro Diagnostics Directive 98/79/EC. All Fujirebio Diagnostics kits are manufactured in one of our ISO13485 certified facilities located in Gothenburg, Sweden or Malvern, PA, USA.

3 COnTEnT Working for better diagnostics 2 Diagnostics for cancer and brain damage 4 GYNECOLOGICAL CANCER CanAg CA125 EIA 5 HE4 EIA 5 CanAg SCC EIA 6 LUNG CANCER CanAg NSE EIA 6 CYFRA 21-1 EIA 7 CanAg ProGRP EIA 7 MESOMARK EIA 10 Marker Significance 8 Product Specifications 9 GASTROINTESTINAL CANCER CanAg CA242 EIA 10 CanAg CEA EIA 11 CanAg CA19-9 EIA 11 PROSTATE CANCER CanAg PSA EIA 12 CanAg Free PSA EIA 12 BREAST CANCER CanAg CA15-3 EIA 13 OTHER Liver Cancer CanAg AFP EIA 13 Malignant Melanoma CanAg S100 EIA 14 TUMOR MARKER CONTROLS CanChek 15 Tumor Marker Control 15

4 Diagnostics for Cancer and Brain Damage Cancer is one of the major causes of death in the western world second only to cardiovascular disease. Every third person will develop cancer and every fourth person will ultimately die from cancer. For improved outcomes and survival rates it is essential to detect cancer early. Biochemical substances are released from cells and can be used as markers of disease in patient blood samples. These biomarkers may be used in cancer diagnosis/management (tumor markers) or as markers of brain damage (Biochemical Markers of Brain Damage, BMBD). Serological tumor and brain damage marker determinations represent an important patient management tool in, among others, the following applications: Technician working with the establishment of new hybridomas in our laboratory in Sweden. Identification of disease at an early stage in combination with other diagnostic tools Generation of prognostic information Follow up of the effectiveness of treatment Monitoring the course of disease Early detection of recurrent disease Laboratory Tests Our tests make it possible to detect and/or monitor all of the most common forms of solid tumors, such as gastrointestinal, squamous cell, liver, pancreatic, prostate, ovarian, breast, skin and lung cancer. The company has also developed markers for brain damage after e.g. acute brain trauma, stroke, and hypoxia. Our kits can be used on a wide range of microplate instruments giving considerable flexibility and cost efficiency for hospitals and laboratories. The kits are available globally through our Distributor Network. 4

5 Gynecological Cancer CanAg CA125 EIA Determination of the CA125 antigen is of clinical utility in ovarian cancer. It can be used for: 1. Differential diagnosis between ovarian tumors and benign disease. 2. Monitoring disease progression and regression. 3. Prognosis of survival time. 4. Early detection of recurrence. Results within: 4 hours Detection limit: < 1.5 U/mL Measuring range: U/mL Hook effect: No hook up to U/mL Prod. No CanAg CA125 EIA HE4 EIA The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The HE4 EIA is intended to be used as an aid in monitoring response to therapy for patients with invasive epithelial ovarian cancer. It is further intended to be used with the CanAg CA125 and ARCHITECT CA 125 II assay for in vitro diagnostic use as an aid in estimating the risk of epithelial ovarian cancer in premenopausal and postmenopausal women presenting with pelvic mass. Numerous published studies show that a woman s outcome is better when her ovarian cancer surgery is performed by a gynecologic oncologist. An estimation of the risk of ovarian cancer in a patient presenting with a pelvic mass may therefore be a helpful tool in determining who should be referred to a gynecologic oncologist for her surgery. Results within: 3 hours Detection limit: < 15 pm Measuring range: pm Hook effect: No hook up to pm Prod. No HE4 EIA 5

6 Gynecological Cancer / Lung Cancer CanAg SCC EIA Squamous cell carcinoma antigen (SCCA) is a serological marker for squamous cell carcinomas (SCC) of the uterine cervix, lung, head and neck, vulva, and esophagus. Serum concentrations of SCCA in patients with SCC are correlated to the clinical stage, tumor volume and to the degree of histological differentiation of the tumor. Results within: 2 hours, one step procedure Detection limit: < 0.3 µg/l Measuring range: < µg/l Hook effect: No hook up to µg/l Prod. No CanAg SCC EIA CanAg nse EIA Determination of NSE antigen is of clinical utility in small cell lung cancer. It can be used for: 1. Differential diagnosis between Non Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC). 2. Monitoring disease progression and regression in patients with SCLC. 3. Early detection of recurrent disease. 4. Prognosis of survival time. Results within: 2 hours, one step procedure Detection limit: < 1 µg/l Measuring range: µg/l Hook effect: No hook up to µg/l Prod. No CanAg NSE EIA 6

7 Lung Cancer CYFrA 21-1 EIA The CYFRA 21-1 EIA is a one-step, solid phase, quantitative assay for the measurement of soluble cytokeratin 19 fragments in serum. The measurement of CYFRA 21-1 levels may be useful in the monitoring and prognosis of non-small cell lung cancer. Elevated levels of cytokeratin 19 fragments are seen in serum from patients also in several other cancers such as esophagus, head-& neck and breast cancer. Results within: 2 hours, one step procedure Detection limit: < 0.5 ng/ml Measuring range: ng/ml Prod. No Sample volume: Hook effect: Stability: Incubation temp: Detection: CanAg CYFRA 21-1 EIA 50 µl No hook up to ng/ml 18 months at 2-8 C C 620 nm or 405 nm CanAg progrp EIA ProGRP is the precursor of the gut hormone GRP (Gastrin Releasing Peptide). ProGRP is stable in serum and has been shown to be elevated in patients diagnosed with Small Cell Lung Cancer (SCLC). The assay is a one-step immunoassay that utilizes biotinylated Anti-ProGRP polyclonal antibody and horseradish peroxidase (HRP) labeled Anti-ProGRP Monoclonal Antibody E146 in Streptavidin coated microtiter strips for the measurement of ProGRP in serum. Results within: 3 hours, one step procedure Detection limit: 2 ng/l Measuring range: ng/l Prod. No Sample volume: Stability: Calibrator range: Incubation temp: Detection: CanAg ProGRP EIA 50 µl 18 months at 2-8 C ng/l C 450 nm 7

8 marker Significance CANCER (localization) CA242 CA19-9 SCC CA125 HE4 CA15-3 NSE CEA CYFRA 21-1 ProGRP MESOMARK PSA Free PSA AFP S100 GASTROINTESTINAL Colorectal Pancreatic Esophagus GYNECOLOGICAL Ovarian Cervical Endometrial LUNG NSCLC SCLC Malignant Mesothelioma Prostate Breast Liver Germ Cell / Testicular Thyroid Head & Neck Melanoma MARKER SIGNIFICANCE less more

9 product Specifications MARKER CATALOG SAMPLE RESULTS DETECTION MEASURING SAMPLE HIGH DOSE NORMAL WITHIN- BETWEEN NUMBER WITHIN LIMIT RANGE VOLUME HOOK RANGE RUN CV (%) DAY CV (%) CA Serum 4 hours < µl > < two-step U/mL U/mL U/mL U/mL CA Serum 4 hours < µl > < two-step U/mL U/mL U/mL U/mL SCC Serum 2 hours < µl > < one-step µg/l µg/l µg/l µg/l CA Serum 4 hours < µl > < two-step U/mL U/mL U/mL U/mL HE Serum 3 hours < µl > < two-step pm pm pm pm CA Serum 3 hours < µl > < one-step U/mL U/mL U/mL U/mL NSE Serum 2 hours < µl < one-step µg/l µg/l µg/l µg/l CEA Serum 2 hours < µl > < one-step µg/l µg/l µg/l µg/l CYFRA Serum 2 hours < µl > 1100 < one-step ng/ml ng/ml ng/ml ng/ml ProGRP Serum 3 hours < µl > one-step ng/l ng/l ng/l MESOMARK Serum 3 hours < µl > < nm nm nm nm PSA Total Serum 2 hours < µl > < one-step µg/l µg/l µg/l µg/l Free PSA Serum 2 hours < µl > n/a one-step µg/l µg/l µg/l AFP Serum 2 hours < µl > < one-step µg/l µg/l µg/l µg/l S Serum 4 hours < µl > 150 < two-step µg/l µg/l µg/l µg/l

10 Lung Cancer / Gastrointestinal Cancer mesomark EIA MESOMARK EIA is an enzyme linked immunosorbent assay for the quantitative measurement of soluble mesothelin related peptide (SMRP). The assay is a standard sandwich assay that utilizes two monoclonal antibodies, 4H3 and OV569, in the capture and detection of SMRP. SMRP has been shown to be elevated in patients diagnosed with malignant mesothelioma, an asbestos related cancer of the pleural lining of the lungs, heart, and abdomen. Results within: 3 hours Detection limit: < 0.3 nm Measuring range: nm Sample volume: 10 µl Hook effect: No hook up to nm Stability: 12 months at 2-8 C Calibrator range: 0-32 nm Detection: 450 nm Prod. No MESOMARK EIA CanAg CA242 EIA CA242 is the latest generation marker of colorectal and pancreatic cancer. The high specificity of CA242 is useful for differentiating between pancreatic cancer and benign hepatobiliary disease. CA242 also gives prognostic information in pancreatic as well as in colorectal cancer. The combined use of CA242 with CEA (Carcino Embryonic Antigen) shows improved sensitivity both pre- and post-operatively. Results within: 4 hours Detection limit: < 1 U/mL Measuring range: U/mL Hook effect: No hook up to U/mL Prod. No CanAg CA242 EIA 10

11 Gastrointestinal Cancer CanAg CEA EIA Carcinoembryonic antigen (CEA) is a general tumor marker, which shows clinical utility in gastrointestinal cancer as well as breast and lung cancer. The CanAg CEA EIA is a solid-phase non-competitive assay based on the direct sandwich technique. The antibodies used target the Gold epitope 4 and 5 for optimal clinical sensitivity and specificity and non-specific interference. Results within: 2 hours, one step procedure Detection limit: < 0.25 µg/l Measuring range: µg/l Hook effect: No hook up to µg/l Prod. No CanAg CEA EIA CanAg CA19-9 EIA CA19-9 is a well established marker for differentiation between malignant and benign pancreas disease, to follow up patients undergoing treatment and to detect recurrence. The incidence of pancreatic cancer continues to increase in the industrialized world. One way to improve the poor prognosis of pancreatic cancer is early detection of the tumor combined with a possibly curative resection. Results within: 4 hours Detection limit: < 1 U/mL Measuring range: U/mL Hook effect: No hook up to U/mL Prod. No CanAg CA19-9 EIA 11

12 prostate Cancer CanAg psa EIA Increasing serum concentrations of PSA (Prostate Specific Antigen) may indicate cancer of the prostate. In patient serum PSA exists in its free form (Free PSA) and in stable complexes with different protease inhibitors. The most important complex is formed with α1-antichymo-trypsin (PSA-ACT). The CanAg PSA EIA determines the total amount of PSA, with the same molar response for free and complexed PSA. Results within: 2 hours, one step procedure Detection limit: < 0.1 µg/l Measuring range: µg/l Hook effect: No hook up to µg/l Prod. No CanAg PSA EIA CanAg Free psa EIA It has been shown that the proportion of free PSA to total PSA in serum is often lower in men with prostate cancer than in men with benign prostatic hyperplasia. Determination of free PSA may therefore be used in conjunction with total PSA as an aid in the differentiation between benign prostatic hyperplasia and prostate cancer. Results within: 2 hours, one step procedure Detection limit: < 0.03 µg/l Measuring range: µg/l Sample volume: 50 µl Hook effect: No hook up to µg/l Detection: 450 nm Prod. No CanAg Free PSA EIA 12

13 Breast Cancer / Liver Cancer CanAg CA15-3 EIA Breast cancer is the third most frequent form of cancer with a mortality rate of approximately 20 per 100,000 women. CA15-3 is primarily used in the management of breast cancer patients, for monitoring the disease, to follow up the effect of treatment as well as for early detection of recurrence. There is also a positive correlation between low preoperative serum levels of CA15-3 and good prognosis. Results within: 3 hours, one step procedure Detection limit: < 1 U/mL Measuring range: U/mL (diluted samples 1:41) Hook effect: No hook up to U/mL Stability: 12 months at 2-8 C Prod. No CanAg CA15-3 EIA CanAg AFp EIA AFP is present in low concentrations in serum, but may be markedly increased in patients with cancer of the liver, testis or ovary. The CanAg AFP EIA is a solid-phase non-competitive assay based on the direct sandwich technique using the AFPK51 MAb and AFPK57 MAb for optimal clinical sensitivity, specificity and non-specific interference. The antigenic determinants of AFP have been characterised in an International Workshop under the auspices of ISOBM (ISOBM TD-2 Workshop). Results within: 2 hours, one step procedure Detection limit: < 0.5 µg/l Measuring range: µg/l Hook effect: No hook up to µg/l Prod. No CanAg AFP EIA 13

14 malignant melanoma S100B is a 20 kda protein belonging to the S100/calmodulin/troponin C super family of EF-hand calcium binding proteins. S100 was originally isolated in 1965 from human brain and was considered as a brain specific protein. Today more than 20 members of the S100 family have been characterised based on structural and functional similarities. In brain tissue, S100B is found as hetero- and homodimers of A1 (α)- and B (ß)-subunits. The A1- and B-subunits show a high degree of sequence and species homology. In the nervous system S100A1B and S100BB dimers exist in high concentration in astrocytes, oligodendrocytes and Schwann cells. S100A1B and S100BB are also expressed in a limited proportion of cells outside the nervous system eg. melanocytes, adipocytes and chondrocytes as well as in certain malignant cells, most notably in melanoma. Serum S100B is a sensitive biomarker for Malignant Melanoma. It is also clinically proven to be useful for management of patients with brain damage CanAg S100 EIA The CanAg S100 EIA is a solid-phase, non-competitive direct sandwich assay. The assay is based on two monoclonal antibodies, S23 MAb and S53 MAb, targeting two regions of S100B exposed in both the S100A1B- and S100BB dimer. This antibody combination provides an assay with similar sensitivity for these two forms of S100B. Results within: 4 hours Detection limit: < 0.01 µg/l Measuring range: µg/l Sample volume: 50 µl Hook effect: No hook up to 150 µg/l Stability: 18 months at 4 C Prod. No CanAg S100 EIA 14

15 Tumor marker Controls CanChek The CanChek tumor marker control is for use as a quality control serum to monitor laboratory testing of Neuron Specific Enolase (NSE), S100B protein and Squamous Cell Carcinoma antigen (SCC). Two levels of the control are provided to enable performance monitoring over the clinical range Control: 3 vials of level 1 3 vials of level 2 Volume: 6 x 0.75 ml Stability: 24 months Prod. No CanChek Control Tumor marker Control Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA. Two levels of the control are provided to enable performance monitoring over the clinical range Control: 3 vials of level 1 3 vials of level 2 Volume: 6 x 3 ml Stability: 24 months Prod. No Tumor Marker Control 15

16 Oncology CanAg CA242 EIA Pancreatic & Gastrointestinal Cancer CanAg CA19 9 ElA Pancreatic Cancer CanAg CA15 3 ElA Breast Cancer CYFRA 21-1 EIA Lung Cancer CanAg ProGrp EIA Lung Cancer CanAg PSA ElA Prostate Cancer CanAg Free PSA EIA Prostate Cancer CanAg CA125 EIA Ovarian Cancer CanAg CEA EIA Gastrointestinal, Breast & Lung Cancer HE4 EIA Ovarian Cancer CanAg NSE EIA Lung Cancer CanAg AFP EIA Liver Cancer CanAg S100 EIA Malignant Melanoma CanAg SCC EIA Squamous Cell Carcinoma MESOMARK EIA Malignant Mesothelioma Fujirebio Diagnostics Inc. 201 Great Valley Parkway Malvern, PA USA phone fax info@fdi.com website Fujirebio Diagnostics AB Elof Lindälvsgata 13 PO Box SE Göteborg Sweden phone fax info@fdab.com website Tumor Marker Controls CanChek Control for SCC, NSE, S Tumor Marker Control Control for HE4, CA 15-3, CA 19-9, CA 125, AFP, CEA, TOTAL PSA, FREE PSA, FERRITIN, CA 27.29, CA 242 Brain Damage CanAg S100 EIA CanAg is a registered trademark of Fujirebio Diagnostics AB EIA Kit Catalogue, March 2011